Artificial Pancreas Project
In 2006, JDRF launched the Artificial Pancreas Project (APP) to accelerate the development of a commercially-viable artificial pancreas as a system to ultimately mimic the biological function of the pancreas for patients with type 1 diabetes.
Currently, people with type 1 diabetes must manually measure levels of glucose in their blood by either using the traditional method of pricking one’s finger, or by using a continuous glucose monitor (CGM), a device that senses glucose levels via a needle inserted under the skin. Then, based on these measurements, they must adjust glucose levels by taking multiple injections of insulin daily or by continually infusing insulin with a pump via needles placed under the skin. In addition, multiple other factors beyond insulin affect glucose values, making control hard in people living a normal life outside a controlled hospital setting. This requires diligence and a tremendous amount of manual effort by the user.
By automating detection of blood sugar levels and delivery of insulin in response to those levels, an artificial pancreas has the potential to transform the lives of people with type 1 diabetes.
The 6-step APP development pathway shown above serves as the APP’s strategic funding plan and defines the priorities of product research and development. Each step in the plan represents incremental advances in automation beginning with devices that shut off insulin delivery to prevent episodes of low blood sugar and progressing ultimately to a fully automated “closed loop” system that maintains blood glucose at a target level without the need to bolus for meals or adjust for exercise.
The first generation products in Steps 1-3 focus on preventing unsafe high and low blood sugar levels and aim to maintain blood sugar between approximately 70 and 180 mg/dL. Steps 1 and 2 focus mainly on preventing episodes of low blood sugar and thus aim to limit the time a person spends below 70 mg/dL. While a Step 1 product suspends insulin delivery in response to low glucose levels, Step 2 product improves the ability to predict impending episodes of low blood sugar and automatically shut off or reduce insulin delivery if the person is unresponsive to warning alarms, rather than waiting for the person to reach a low blood sugar level. Such a system may not prevent all episodes, but will significantly reduce these events compared with current treatment options.
Step 3 in the plan adds a feature that prevents unsafe high blood sugar levels, in addition to low blood sugar levels, hence the name ‘hypoglycemia/hyperglycemia minimizer.’ This product represents a first-generation, semi-automated, artificial pancreas product concept since the user will still need to set baseline insulin delivery, as well as bolus for meals. The current vision for this first-generation artificial pancreas product will likely be realized through the JDRF/Animas partnership in the next few years, representing a significant step forward in diabetes management that could minimize dangerous highs and lows.
Steps 4 and 5 of the plan represent second-generation product concepts with Step 4 referred to as a “hybrid closed-loop” product because it will target a specific blood sugar level instead of a range, but bolusing for meals will still be necessary. The next advance shown in Step 5, would eliminate manual pre-meal boluses to result in a fully automated, closed-loop artificial pancreas product. These product concepts will require research and development of advanced insulins and improved glucose sensing technologies.
Finally, a third-generation product concept shown in Step 6, adds the ability to dose a second or potentially more drugs to more closely mimic the way the body maintains blood sugar levels and further improve blood sugar control. This concept will require pumps that can deliver two or more solutions, as well as the development and approval of additional hormonal drugs.
All these advances will require strategic partnerships with industry as well as with academic researchers in order to address gaps in technology and to spur the innovation necessary to deliver successively more sophisticated generations of artificial pancreas products for people with type 1 diabetes.